Freedom 1000 FM1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00670482000487), received between Mar 24, 2022 and Jan 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

2 FDA recall records name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 11, 2022Terminated

   There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

   Z-1135-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Apr 11, 2022Terminated

   There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

   Z-1136-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Flare or Flash; Flare or Flash

  CUSTOMER REPORTED THAT A CRACKLING SOUND AND AN ELECTRICAL FLASH WAS NOTICED FROM A REMOVABLE POWER CORD CONNECTED TO THE BED. HE MENTIONED THAT EVERYTHING STOPPED ONCE THE BED WAS UNPLUGGED. NO PATIENT INJURY WAS REPORTED. THE NURSE CUT HER HAND WHILE REACHING THE BED. A MANUFACTURER SERVICE TECHNICIAN VISITED THE SITE TO INVESTIGATE THE DEVICE. THE POWER CORD WAS REPLACED, AND THE BURN MARK ON THE HEAD SECTION OF THE BED WAS REMOVED. THE BED IS NOW FUNCTIONING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183226 ↗
• MalfunctionSep 6, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO UMANO MEDICAL REPRESENTATIVE THAT THE BED IS NOT SENDING SIGNAL TO THE HOSPITAL'S NURSE CALL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160448 ↗
• MalfunctionMar 24, 2022Failure to Shut Off; Unintended Movement; Failure to Shut Off

  DISTRIBUTER CONTACTED TECHNICAL SERVICE OF THE MANUFACTURER TO REPORT AN ISSUE WITH THE MOTORIZED WHEEL SYSTEM OF A HOSPITAL BED THAT WAS BEING USED BY ONE OF HIS CUSTOMERS DURING A TRIAL SESSION (THE BED WAS NOT IN USE WITH A PATIENT) HE MENTIONED THAT WHEN THEY RELEASED THE TRIGGER TO STOP THE WHEEL MOVEMENT, THE BED CONTINUED TO MOVE FORWARD AND WAS STOPPED AGAINST THE WALL. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892885 ↗